α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 3 - February 27, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))

EC Number:

406-420-4

EC Name:

α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))

Cas Number:

69430-40-6

Molecular formula:

Unspecified example: C18.3H46.8O5.8Si4.1

IUPAC Name:

2,2,4,4,6,12,15-heptamethyl-6-[(trimethylsilyl)oxy]-3,5,10,13,16-pentaoxa-2,4,6-trisilaheptadecane

Details on test material:

Identification: DC 5067
Description: Clear, light brown liquid
Lot Number: AB 090122
Purity: >99%
Storage conditions: In the original container at room temperature in the dark
Stability under storage conditions: Stab1e
Expiry date: December 1, 1991

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 hours

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 65 min., 24 hrs, 48 hrs, 72 hrs

Score:

>= 1 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Erythema also outside treated site.

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 65 min., 24 hrs, 48 hrs, 72 hrs

Score:

>= 0 - <= 1

Max. score:

1

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Oedema also outside treated site.

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 65 min., 24 hrs, 48 hrs, 72 hrs

Score:

>= 0 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 14 Tage

Remarks on result:

other: Ervthema also outside treated site.

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 65 min., 24 hrs, 48 hrs, 72 hrs

Score:

>= 0 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Ervthema and oedema also outside treated site.

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 65 min., 24 hrs, 48 hrs, 72 hrs

Score:

>= 1 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Ervthema and oedema also outside treated site.

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 65 min., 24 hrs, 48 hrs, 72 hrs

Score:

>= 1 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: 65 min., 24 hrs, 48 hrs (all animals): Ervthema and oedema also outside treated site. 72 hours/animals 2 and 3: Erythemaalso outside treated side.

Other effects:

No other effects observed.

Any other information on results incl. tables

The observed skin irritation consisted of well defined erythema and very slight or slight oedema in the three animals. The skin irritation was reversible within 14 days after exposure in all animals.

No staining of the treated skin by the test substance was observed.

There was no evidence of a corrosive effect on the skin.

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DC 5067 resulted in a primary irritation index of 2.3 (moderately irritating) when applied to the intact rabbit skin.
According to the EEC criteria for classification and labelling requirements for dangerous substances (EEC Directive 83/467/EEC, Annex VI of the EEC Council Directive 67/548/EEC), DC 5067 need not be labelled as a skin irritant.

Executive summary:

The purpose of this study was to assess the possible irritation or corrosion potential of DC5067 when a single dose was placed on the skin of rabbits. This study was carried out in accordance with OECD Guideline Number 404, "Acute Dermal Irri tation/Corrosion and EEC Directive 84/449/EEC, Part 8.4, "Acute Toxicity-Skin Irritation". DC5067 was applied on the shaved skin of three female rabbits using semi-occlusive dressings for 4 hours, followed by six observations at approximately 1, 24, 48 and 72 hours and 7 and 14 days after removal of the dressings and the remaining test substance. Under the conditions of this study, DC5067 resulted in well defined erythema and very slight or slight oedema in the three animals. The skin irritation was reversible within 14 days after exposure in all animals. In the area of application, no staining of the treated skin in any of the rabbits. No signs of systemic intoxication were observed during the study period.